ERYTHROCYTE TEST

Red-cell Count By Photometry

BIO-ANALYTICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-analytics Laboratories, Inc. with the FDA for Erythrocyte Test.

Pre-market Notification Details

Device IDK832771
510k NumberK832771
Device Name:ERYTHROCYTE TEST
ClassificationRed-cell Count By Photometry
Applicant BIO-ANALYTICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLKZ  
CFR Regulation Number864.7100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-16
Decision Date1983-10-28

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